European Journal of Biomedical and Pharmaceutical Sciences

A COMPARATIVE, RANDOMIZED, DOUBLE BLIND, MULTICENTRIC, ACTIVE CONTROLLED, PARALLEL GROUP, TWO ARM, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF FIMASARTAN TABLETS VS. LOSARTAN TABLETS IN PATIENTS WITH MILD ESSENTIAL HYPERT

*Dr. Shailesh Singh, Dr. Karuna Ramteke, Khushwant Khatri and Pravin Hule

ABSTRACT

Background: The present study was designed to evaluate the efficacy, safety and tolerability of Fimasartan Tablets vs. Losartan Tablets in Patients with Mild Essential Hypertension. The main objective of the study was to evaluate mean reduction in the sitting clinic SBP from baseline to Day 90 (±2) after 10 minutes rest period, mean reduction in the sitting clinic DBP from baseline to Day 90 (±2) after 10 minutes rest period, mean reduction in ABPM Parameters from baseline to Day 90 (±2) (Mean 24hour SBP and DBP, Mean Day Time SBP and DBP, Mean Night Time SBP and DBP). Method: It was a comparative, randomized, double blind, active controlled, parallel group, two arm, multicentric clinical trial conducted in 13 center across India in patient with Mild Essential Hypertension. The recruitment has been started from Oct 10, 2017 to Feb 03, 2018. Total 215 patients (aged 18-65 years) were randomized in the ratio 1:1 in both arms. All the patients were advised to take one tablet daily either Fimasartan Tablets or Losartan Tablets in the morning as per randomization. The treatment continued for 90 days with periodic follow up on 7th, 15th, 30th, 60th and 90th days from start of treatment. Result: The current study showed the mean reduction in systolic blood pressure and diastolic blood pressure as 14.48 mmHg and 9.46 mmHg respectively for Fimasartan tablets and 13.91 mmHg and 8.79 mmHg respectively for Losartan tablets. There were 19 adverse events reported (Fimasartan; 05, Losartan; 13) in the study and which were mild in nature. Conclusion: Fimasartan Tablets 60 mg / 120 mg was Non-Inferior to Losartan 50 mg / 100 mg in terms of efficacy and safety in the treatment of patients with mild essential hypertension.

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